Normal Values of Oxidative Stress, Taurine, and Related Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Oxidative stress marker: TBARS
研究概览
简要总结
The role of oxidative stress in disease pathology is increasingly recognized. At present, the development of biomarkers of this state is in its infancy and the availability of clinically validated assays is lacking. This study will better determine normal values for specific biomarkers of oxidative stress. It will also investigate normal values of taurine, a natural occurring oxidative stress protectant. A primary and specific application of this data is for the evaluation of oxidative stress, levels of the natural protectant taurine, and of associated inflammation in the context of cystathionine β-synthase (ClinicalTrials.gov study: Oxidative Stress Markers in Inherited Homocystinuria and the Impact of Taurine).
详细描述
This study is a one-time collection of blood and urine samples in healthy individuals. Subjects have to be fasting for 3 hours prior to the blood sampling. A maximum of 7.5 mLs of blood (1 and 1/5 teaspoon) and a urine sample will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: Over 8 years old and less than 50 years
排除标准
- •Pregnancy: Females who are pregnant or lactating will be excluded from the study as the influence of pregnancy on the markers is not known nor is the impact of pregnancy on taurine known.
- •Antioxidant use: Individuals taking taurine, over the counter energy drinks containing taurine or other high dose antioxidants such as Vitamin C or E, coenzyme Q, carotenes, selenium will be excluded as such intake will likely impact laboratory results.
- •Inflammatory status:
- •Individuals who have a significant chronic illness or state that has a known or suspected marked inflammatory component or oxidative stress component will be excluded from the study as the illness will impact inflammatory markers.
- •Patients with an acute illness, which may impact inflammatory biomarkers, will be postponed for study entry until the acute illness is resolved. Entry into the study at a later day will be offered. The study visit will not be conducted within 3 weeks of the acute illness.
- •Smoking within the past 12 months will be excluded.
结局指标
主要结局
Oxidative stress marker: TBARS
时间窗: Time 0
Single Draw for one-time analysis
Metabolite antioxidant: Taurine
时间窗: Time 0
Single Draw for one-time analysis
次要结局
- Vascular function: Thromboxane B2 metabolites(Time 0)
- Oxidative stress: dityrosine(Time 0)
- Inflammation markers: IL1α, IL-1β, IL10, TNFα(Time 0)
- Inflammation marker: high sensitivity CRP(Time 0)
- Inflammation markers: cytokines: TNFα, IL4, IL10 and IL12(Time 0)
- Inflammation marker: myeloperoxidase(time 0)
- Metabolites: S-adenosylmethionine and S-adenosylhomocysteine(Time 0)
- Inflammation marker: Supper oxide dismutase (SOD)(Time 0)
- Inflammation marker: TGFβ(Time 0)
- Inflammation markers: cytokines: IL1α, IL-1β IL-1ra, IL6, IL8, IL17, MCP-1,MIP-1, MIP1α, MIPβ(Time 0)